MRE Consumption and Gut Health
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ClinicalTrials.gov Identifier: NCT02423551 |
Recruitment Status :
Completed
First Posted : April 22, 2015
Last Update Posted : April 16, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gastrointestinal Tract | Other: MRE | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 71 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | Effects of Meal, Ready-to-Eat (MRE) Consumption on Gut Health |
Actual Study Start Date : | April 2015 |
Actual Primary Completion Date : | February 2017 |
Actual Study Completion Date : | February 2017 |
Arm | Intervention/treatment |
---|---|
No Intervention: Control
Usual diet
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Experimental: MRE
MRE consumption
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Other: MRE
MRE consumption |
- Change in gut barrier integrity [ Time Frame: Baseline to 10 days, 21 days and 31 days ]Urine excretion of saccharide probes; circulating zonulin, intestinal fatty acid binding protein, claudin-3, lipopolysaccharide and GLP2 concentrations
- Change in gut microbiota composition [ Time Frame: Baseline to 10 days, 21 days and 31 days ]16S rRNA gene sequencing
- Change in C-reactive protein concentrations [ Time Frame: Baseline to 10 days, 21 days and 31 days ]Serum C-reactive protein
- Change in TNF-alpha concentrations [ Time Frame: Baseline to 10 days, 21 days and 31 days ]Serum TNF-alpha
- Change in interleukin-6 concentrations [ Time Frame: Baseline to 10 days, 21 days and 31 days ]Serum IL-6
- Change in lipopolysaccharide concentrations [ Time Frame: Baseline to 10 days, 21 days and 31 days ]Plasma LPS
- Change in iron status [ Time Frame: Baseline to 10 days, 21 days and 31 days ]Blood ferritin, soluble transferrin receptor, hemoglobin, hematocrit
- Change in vitamin D status [ Time Frame: Baseline to 10 days, 21 days and 31 days ]Blood 25-hydroxyvitamin D, 1,25-dihydroxyvitamin D, parathyroid hormone
- Change in B-vitamin status [ Time Frame: Baseline to 10 days, 21 days and 31 days ]Blood folate, vitamin B12, homocysteine
- Change in nutritional status [ Time Frame: Baseline to 10 days, 21 days and 31 days ]Blood prealbumin
- Change in calcium absorption [ Time Frame: Baseline to 10 days, 21 days and 31 days ]Urine calcium
- Change in zinc status [ Time Frame: Baseline to 10 days, 21 days and 31 days ]Blood zinc, zinc receptor expression

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Ages Eligible for Study: | 18 Years to 62 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- BMI </= 30
Exclusion Criteria:
- Use of antiobiotcs within 3 months of study participation
- Use of pro- or prebiotic supplements within 2 weeks of study participation
- Vegetarian diets
- Use of laxatives, stool softeners, or anti-diarrheal medications at least once a week.
- Fewer than 4 bowel movements, on average, per week
- History of gastrointestinal disease
- Colonoscopy within 3 months of study participation
- Food allergies or aversions or other issues with foods that would preclude MRE consumption, including gluten, milk, nuts, or eggs.
- Use non-steroidal anti-inflammatory medications (NSAIDs) or antihistamine prescribed by a physician or clinician, or unwillingness to discontinue the use of these substances during the study.
- Actively trying to lose weight
- Pregnant or lactating
- Recent blood donation

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02423551
United States, Massachusetts | |
USARIEM | |
Natick, Massachusetts, United States, 01760 |
Responsible Party: | James Philip Karl, Research Dietitian, United States Army Research Institute of Environmental Medicine |
ClinicalTrials.gov Identifier: | NCT02423551 |
Other Study ID Numbers: |
15-12HC |
First Posted: | April 22, 2015 Key Record Dates |
Last Update Posted: | April 16, 2019 |
Last Verified: | April 2019 |
Gut microbiota Intestinal permeability Gut barrier integrity |